Marketing Authorization

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Marketing Authorization: a guarantee of safety and efficacy for patients

Marketing Authorization is a procedure that has become widespread in most countries of the world, under the control of the States, to guarantee the safety and efficacy of medicine for patients, from their design to their withdrawal from the market (concept of life cycle). Drugs must receive a Marketing Authorization before being introduced on the European or French market.

A drug is legally defined as:

  • a substance or composition presented as having curative or preventive properties in respect of diseases, or
  • a substance or combination of substances which may be administered for the purpose of making a medical diagnosis, or
  • a substance or composition that may be administered to restore, correct, or modify organic functions.

Certain claims or therapeutic allegations made for certain cosmetic products or food supplements may therefore incur the wrath of the regulatory authorities.

Main steps in the design of a drug before Marketing Authorization

MA is the culmination of a long process of designing a safe and effective drug. This process usually takes about 15 years.

In general terms, the main stages in the life of a drug from conception to marketing are as follows. (1)


Fig.1 Lifetime of a medicine and marketing authorization (1)


Exploratory research combines, for the chemical drug, the synthesis of multiple variations from the same basic skeleton, or the reuse of existing molecules in databases. The molecules most likely to give a pharmacological action are selected either by tests on in vitro, in vivo (cell models) or in silico (computer models, based on docking or QSAR[i] studies) models. After this screening, only about one hundred molecules are eligible for the start of pharmacological trials. In the end, for the MA application, there will only be one left!

Then come the preclinical trials and the clinical trials. (1)

The purpose of preclinical trials is to check the tolerance of molecules in vitro in animals, to carry out toxicological tests and to study the pharmacokinetics of molecules (in short, to see how quickly the molecules act, are absorbed or are eliminated).

The clinical research (about 7 years of work) is divided into three main phases:

  • phase I: tolerance + metabolism
    • trials in human patients, on a small cohort of healthy volunteers. These trials aim to test the tolerance of molecules in patients and to determine human pharmacokinetics.
  • phase II: efficacy + optimal dose
    • trials in human patients, on a larger cohort of sick volunteers (but without other pathologies).
    • these trials aim to establish a benefit/risk ratio for the molecule and to define the effective doses, the route of administration and the optimal therapeutic dose.
  • phase III: efficacy + safety
    • trials in human patients, on a large cohort of sick volunteers under real conditions.
    • these trials are specifically designed to verify efficacy (“double-blind” study) vs. reference drug (or, failing that, placebo) and long-term tolerance.

During the marketing phase, a “pharmacovigilance” system is set up: potential side effects are collected from health professionals and may give rise to observational studies.

In addition, interventional studies (so-called phase IV) may be carried out, particularly if the marketing authorization requires it because of the low number of patients in clinical trials. These studies are carried out under conditions close to the normal management with the aim of identifying any rare adverse effects not detected during the previous phases (pharmacovigilance) and to specify the conditions of use for certain groups of patients at risk. This phase makes it possible to analyse drug interactions and promotes the development of new galenic forms as well as extensions of therapeutic indications.

During the marketing phase, secondary clinical studies may be conducted at the initiative of the manufacturer to test the drug on another disease, a new population, as part of a new therapeutic strategy, etc. to obtain approval for a new indication.



[i] Quantitative Structure-Activity Relationships


Once the precious sesame has been obtained, it is necessary to continue to be able to protect the drug. To do this, various provisions exist.


Drugs are patentable under common patent law. Pharmaceutical patents are granted, like all other patents, for a period of 20 years from the date of filing, subject to the payment of annal fees. However, the duration rules for drug patents differ from the general patent law regime.

Drugs require a marketing authorization (AMM) before they can be marketed. This authorization is generally not granted for several years. The drug would therefore in reality only be protected by the patent for about ten years. To compensate for this period during which the patent cannot be exploited, a special title has been created, the Supplementary Protection Certificate (SPC), which extends the rights of the patent holder over a pharmaceutical product for a period of 5 years, thus compensating for the problem of waiting for MA, which can take several years and during which the drug cannot be marketed.

The application for a community supplementary protection certificate must be filed within six months of obtaining the marketing authorization, or within six months of obtaining the patent if the patent was granted after the marketing authorization. The Community supplementary protection certificate is ancillary to the patent in the sense that if the drug patent is invalid, so is the certificate. It is possible to patent a molecule which is already known and for which a first application has already been disclosed, if the patent application relates to a new therapeutic application of that molecule.

As of July 1, 2019, Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products has been amended to allow EU-based manufacturers of generics and biosimilars to manufacture in the EU products or medicinal products containing these products, for export to third country markets or for storage pending the expiry of a certificate. This amendment introduces an exception limiting the protection conferred by a certificate and provides that certain acts which would otherwise require the consent of the holder of the certificate may be carried out without being considered an infringement of the holder right’s...

In practice, the drug is on average commercially protected for about fifteen years (duration of patent validity at the time of the extended marketing of the SPC).


Finally, the duration of protection granted by the SPC is:

  • if the MA is granted more than 10 years after the filing of the patent application: 5 years.
  • if the MA is granted earlier than 10 years, the 5-year period is reduced accordingly.

Fig.2 Duration of protection conferred by a SPC (EU Regulation) (1)


Paediatric extension

If the holder of an SPC provides the results of studies conducted according to a paediatric investigation plan (in part or in full in the 0-18 age group) agreed in his MA or supplementary MA file, he is entitled to a 6-month extension of his SPC.

However, this extension is not possible:

  • if the medicinal product is designated in the marketing authorization as targeting a paediatric orphan disease (the complementary protection of the marketing authorization has already been granted).
  • if the marketing authorization benefits from an additional one-year protection granted in case of a new therapeutic indication.




Bibliography, for more information:

  2. Public Health Code